Vanda Pharmaceuticals Inc. (Vanda) announced that it secured a landmark victory over the U.S. Food and Drug Administration (FDA) in its longstanding dispute with the agency regarding the approvability of HETLIOZ® (tasimelteon) to treat jet lag disorder
Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Macitentan Tablets, 10 mg.
The U.S. Food and Drug Administration has approved Wegovy (semaglutide) injection to treat metabolic-associated steatohepatitis (MASH) in adults with moderate-to-advanced fibrosis (excessive scar tissue in the liver).
Masters of Science in Chemistry. 3 years experience in Research and Development in Industrial and Academic Institutions or Science and Technology Organizations and Scientific activities and services
The successful applicant in this role will work on projects including Analytical Method Development and evaluation for in-process samples for synthetic chemistry.
M.Sc. in Biotechnology / Life Sciences with at least 70% marks. Experience in handling mammalian cell culture and skills in microscopy & molecular biology are highly desirable.
Centaurs USFDA and MHRA approved plant is seeking deserving candidates having experience working in Oral Solid Dosage Manufacturing facilities for regulatory markets.
Natco Pharma is an Indian multinational pharmaceutical company based in Hyderabad. The company manufactures finished dosage formulations active pharmaceutical ingredients and crop health science products, and also provides contract manufacturing services.
To ensure the compliance of internal/ external audit and to ensure timely adequate response of audit finding from the department to the auditor to close the issue.
Responsible for leading and managing applications through the regulatory approval process, including preparation of Post Approval Submissions to Health Canada, to obtain timely approvals
Clinical Scientist will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct
To have an oversight on CRO partners for outsourced studies by conducting oversight quality visits at sites if applicable, conduct regular meetings and seek regular updates on study progress.
Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly.